Regulatory Affairs Specialist ensuring compliance for global product distribution at BD. Responsible for maintaining high - quality regulatory data and collaborating across multiple functions.
About the role
- Senior Regulatory Professional developing regulatory strategies for Novo Nordisk's GLP-1 portfolio. Collaborating with cross-functional teams in submission processes to Health Authorities.
Responsibilities
- Develop regulatory strategies and lead execution via interactions with cross-functional teams
- Participate in the development of regulatory documentation for submission to Health Authorities
- Provide regulatory input and contribute to project team decisions
- Interact with medical and non-clinical specialists, statisticians, and medical writers
- Report to the head of the department and participate in department related activities
Requirements
- Master’s degree or Ph.D. in science, pharmaceutical or health science
- Minimum 5 years of experience in the pharmaceutical industry
- Solid and hands-on regulatory experience focusing on drug development and lifecycle activities
- Ability to communicate in fluent English (both written and spoken)
Benefits
- Opportunities to learn and develop
- Health insurance
- Retirement plans
- Professional development
- Potential short-term and long-term incentives
- Employee benefits based on position level and location
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